[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100507605":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":12,"centralContacts":25,"locations":31,"responsibleParty":76,"collaborators":12,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":82,"acronym":12,"eligibilityCriteria":83,"healthyVolunteers":80,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":12,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":12,"overallStatus":34,"whyStopped":12,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Major Extremity Trauma Research Consortium","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Control Pressure Monitoring Group","NO_INTERVENTION","Participants in this group will have pressure monitoring of the anterior compartment of their leg using an indwelling IMP catheter (MY01, MY01 Inc., Montreal, CA). The participants will be treated according to the standard-of-care regarding management of their underlying injury and diagnosis of ACS as practiced by their treating surgeon. Participants will be followed for six months post-injury.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Tissue Ultrafiltration Intervention Group (TUF)","EXPERIMENTAL","Participants in this group will have pressure monitoring of the anterior compartment of their leg using an indwelling IMP catheter (MY01, MY01 Inc., Montreal, CA). The participants will be treated according to the standard-of-care regarding management of their underlying injury and diagnosis of ACS as practiced by their treating surgeon. In addition, participants in this group will will undergo three TUF of the anterior compartment of the injured limb. Participants will be followed for six months post-injury.",[18],"Device: Tissue Ultrafiltration Catheters",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"DEVICE","Tissue Ultrafiltration Catheters","patients randomized to the experimental arm will have three TUF catheters placed in the anterior muscle compartment of the injured limb. The TUF catheters will be connected to a closed suction drain and will remove interstitial fluid from the muscle.",[14],[26],{"name":27,"role":28,"phone":29,"phoneExt":12,"email":30},"Dana Alkhoury, MPH","CONTACT","(410) 955-7498","dalkhou1@jhu.edu",[32,46,56,66],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":12},"University of Maryland School of Medicine R Adams Cowley Shock Trauma Center","RECRUITING","Baltimore","Maryland","21201","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-76.61219,39.29038,{"lat":44,"lon":43},{"facility":47,"status":34,"city":48,"state":49,"zip":50,"country":38,"countryCode":39,"cosmosGeoPoint":51,"geoPoint":55,"contacts":12},"Hennepin Healthcare Research Institute","Minneapolis","Minnesota","55415-1623",{"type":41,"coordinates":52},[53,54],-93.26384,44.97997,{"lat":54,"lon":53},{"facility":57,"status":34,"city":58,"state":59,"zip":60,"country":38,"countryCode":39,"cosmosGeoPoint":61,"geoPoint":65,"contacts":12},"Atrium Health Musculoskeletal Institute","Charlotte","North Carolina","28207",{"type":41,"coordinates":62},[63,64],-80.84313,35.22709,{"lat":64,"lon":63},{"facility":67,"status":34,"city":68,"state":69,"zip":70,"country":38,"countryCode":39,"cosmosGeoPoint":71,"geoPoint":75,"contacts":12},"Vanderbilt University Medical Center","Nashville","Tennessee","37232",{"type":41,"coordinates":72},[73,74],-86.78444,36.16589,{"lat":74,"lon":73},{"type":77,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR","100507605","evaluation-of-the-diagnostic-and-therapeutic-value-of-tissue-ultrafiltration-in-patients-at-risk-of-acute-compartment-syndrome-acs-100507605",false,"NCT05889559","Evaluation of the Diagnostic and Therapeutic Value of Tissue Ultrafiltration in Patients at Risk of Acute Compartment Syndrome (ACS)","INCLUSION CRITERIA The target population for this study include adults ages 18-60 with high-energy injuries of the upper leg considered at risk for ACS at time of admission by virtue of their mechanism of injury, fracture pattern, clinical signs, or need to undergo fracture fixation surgery (internal or external fixation) within 48 hours of admission. Recruitment of participants will happen during hospital admission for treatment of injury.\n\nEligible patients must meet all of the following criteria and be enrolled during one of two possible times: within 14 hours of injury, or prior to undergoing surgical intervention (internal or external fixation on the injured limb) within 48 hours of admission. Eligible patients will be:\n\n1. Between the ages of 18 and 60 years\n2. Have sustained a high-energy upper leg injury such as open or closed proximal tibial shaft fracture with displacement, comminution, or segmental pattern; proximal fibula fracture; bicondylar tibial plateau fracture; Schatzker IV medial knee fracture-dislocation; proximal leg injury due to shotgun, rifle, or other projectile, or severe crushing injury.\n3. Patient can be enrolled in the study and study procedures initiated within 14 hours of injury,\\* or be enrolled prior to undergoing urgent surgical intervention on the injured limb (defined as internal or external fixation) within 48 hours of admission.\n4. Patient (or authorized legal representative) willing to sign informed consent.\n\n   * If a patient has an eligible injury and is going to surgery within 2 hours (except for fasciotomy - which is an exclusion criteria), the patient can be enrolled and the study procedures initiated at the end of surgery. If an eligible patient is enrolled and there is no surgery anticipated within 2 hours, initiate study procedures immediately.\n\nEXCLUSION CRITERIA\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Patients not willing to participate\n2. Patients with non-traumatic cases of acute compartment syndrome (e.g. severe exertion, snakebite, high-pressure injection injury)\n3. Patients diagnosed with ACS or impending ACS such that immediate fasciotomy is recommended\n4. Soft tissue wounds, including lacerations or abrasions, that are in a location that will interfere with safe insertion of indwelling pressure or TUF catheters (anterior - anterolateral aspect of the leg)\n5. Patients not likely to follow-up (are homeless, incarcerated, live out-of-state).\n6. Patients with known peripheral vascular disease\n7. Non-ambulatory due to an associated complete spinal cord injury; Non-ambulatory before the injury due to a pre-existing condition.\n8. Very low clinical concern for ACS at time of admission.","ALL","18 Years","60 Years",{"count":88,"type":89},60,"ESTIMATED","INTERVENTIONAL",[92],"NA","The goal of this clinical trial is to learn if tissue ultrafiltration (TUF) catheters can reduce intramuscular pressure and prevent acute compartment syndrome (ACS) in adults ages 18-60 with severe proximal tibia or tibial shaft fractures.\n\nThe main questions it aims to answer are:\n\nWill intramuscular pressure (IMP) be lower in the TUF cohort compared to controls?\n\nWill the consensus likelihood of ACS, incidence of fasciotomy, and 6-month functional outcomes be better in the TUF cohort?\n\nAre interstitial fluid biomarkers predictive of ACS?\n\nResearchers will compare patients randomized to TUF catheters (n=30) versus control patients receiving standard-of-care only (n=30) to see if TUF lowers ACS risk and improves recovery.\n\nParticipants will:\n\nBe enrolled within 14 hours of injury or prior to high-risk surgery within 48 hours.\n\nReceive continuous anterior compartment pressure monitoring.\n\nUndergo standard-of-care clinical evaluation and treatment.\n\n(TUF arm only) Have three TUF catheters placed in the injured limb to remove interstitial fluid.\n\nReturn for a 6-month follow-up to assess complications, healing, muscle function, and patient-reported outcomes.\n\n(Hennepin Healthcare subset) Provide interstitial fluid samples for biomarker analysis.",[95,96,97],"Acute Compartment Syndrome","Fracture, Bone","Tibial Fractures","2025-08-21",{"date":100,"type":101},"2025-08-28","ACTUAL",{"date":103,"type":101},"2024-01-01",{"date":105,"type":89},"2026-07-01",{"name":5,"class":6},4]